This invention relates to a packaging and dispensing container system including a flexible dispensing container which is constructed of a noncontaminating fluorocarbon or fluorinated hydrocarbon material such as fluorinated ethylene propylene (FEP) material and which is used for the packaging and storage of high purity solutions and solvents which are used in the medical, biomedical and industrial research laboratories for performing critical chemical analyses of various chemical and biological materials.
One of the objects of this invention is to provide a package which does not contaminate various solvents which have been produced by distillation to an ultrahigh purity. The present method of packaging these solvents is by placing them in glass bottles, which, in itself, has been found to have a tendency to contaminate the materials in the glass bottles by a process of leaching out the impurities in the glass container.
Another object of the invention is to provide a dispensing package for high purity liquids which does not require the opening of the container, such as by unscrewing a cap as is conventionally done, to dispense the packaged solvents or solutions. The presently used methods of packaging the aforementioned solvents or solutions requires the user or researcher to open a bottle by unscrewing a cap, thus breaking the seal. This allows contaminating ambient atmosphere to immediately enter the package thus contaminating the materials therein contained with dust and various gasses contained in the ambient atmosphere. Also, as the solvents or solutions are poured out of the usual dispensing bottle, which in some cases exposes the user to toxic and noxious materials, the volume of the solution in the bottle is diminished and is replaced by a like volume of the contaminating ambient atmosphere in which the container is located, thus further contaminating the high purity materials remaining in the bottle. For this reason a significant quantity of expensive high purity liquid is lost to excessive contamination rendering it unsuitable for use.
Another object of the invention is to allow the user to open a dispensing container a maximum of one time to permit dispensing of the contained materials over an extended period of time. According to the present invention, after the fluorocarbon plug sealing the outlet tube is removed, the user places a stopcock type valve, which is manufactured of non-contaminating perfluoro alkoxyl (PFA) material, on the open end of the outlet tube by means of a compression fitting, which is a molded integral part of the stopcock thus again closing the outlet tube against invasion of the ambient atmosphere. The package is now ready to dispense the high purity liquid by suspending the package at an elevated position by means of a supporting rod such as the support arm of a conventional IV stand. To dispense the liquid, the user may open the valve and dispense the liquid material directly into a container which has been prepared to receive the liquid, or the user may attach a non-contaminating length of fluorocarbon tubing such as polytetrafluoroethylene (PTFE), FEP or PFA tubing to the opposite end of the stopcock valve and deliver the liquids to any part of the laboratory without contaminating the ultrapure liquid and with a minimum of exposure to the user to possible toxic or noxious materials such as some ultrapure solvents.
Another object of the invention is to provide for easy dispensing of the packaged liquid from a flexible container by utilizing ambient atmospheric pressure to cause collapsing of the flexible container as the liquid is dispensed and thus utilizing sufficient hydrostatic pressure to dispense the materials without exposure to the atmosphere and contaminating the purity of the liquid being dispensed, as well as ensuring minimal exposure of the user to possible noxious or toxic vapors.
Another object of this invention is to provide a chemically inert package for controlled dispensing of intravenous solutions to medical patients who require medications via a needle placed in a vein and a length of chemically inert tubing placed between the flexible container and the needle. Current flexible containers used in the medical field for intravenous application are typically fabricated from vinyl chloride to produce a "vinyl" bag. This material, which contains vinyl chloride, could be a possible source of vinyl chloride particulate matter, which is a suspected carcinogenic hazard to medical patients. This vinyl chloride particulate is liberated from the bag material due to its chemical instability and could enter the human body along with the intravenous solution via the connecting tubing and the needle placed in the vein of the patient. Also, the silk screen printing on the outside of the vinyl bag has a tendency to permeate through the thin PVC sheet material, thus entering trace quantities of ink into the intravenous solution and consequently into the human body via the intravenous connection.
For protection of the flexible FEP container of this invention, which is relatively fragile due to the relative inflexibilities of fluorocarbon construction material, a protective outer enclosure, such as may be composed of expanded polyurethane may be employed to provide external support for the outer seams of the container as well as the basic wall structure of the flexible container.
The outer package is utilized to provide container stability and to prevent possible rupture of the heat sealed seams of the flexible container during shipment and use. The protective outer enclosure is typically injection molded to provide an internal cavity conforming to the shape of the flexible container when it is filled with solution, thus giving maximum protection and cushioning during the handling of the package during shipment, storage and use.
Another object of the invention is to provide a protective enclosure capable of preventing light penetration into the liquid material within the flexible container. Some solvents or materials to be packaged in the container might be light sensitive and could become degraded due to exposure to light. By coating the inside of the expanded polyurethane protective enclosure or outer package with a light-blocking material, such as a water base black paint or black vinyl sheeting or any other light blocking material, the bag contained within the protective enclosure is never exposed to light to possibly degrade the materials contained therein.
Another object of the protective enclosure is to prevent the outlet tube, which is connected to the FEP container, from being forced into the container and possibly rupturing the container. A frangible protective tube, such as may be constructed of heavy paper, cardboard or of any other suitable material, is scored to provide easy breaking when the package is to be used to dispense the contained liquids. This protective tube will have a flare or flange on the end fitting into the expanded polyurethane protective enclosure, which will have a receiving ring to accept the flanged or flared end. When the two halves of the protective enclosure are placed together, they will secure the protective sleeve in assembly with the protective enclosure.
Another object of the outer package is to provide a surface on which identifying labels may be placed. Since few adhesive materials will adhere to the FEP material from which the flexible containers are fabricated, the protective enclosure will provide an appropriate receptacle for identifying labels.
Another object of this invention is to provide a protective enclosure having support structure enabling the enclosure to provide the bag and its contents to be suspended as a dispensing unit from a support rod. In some instances, the protective enclosure may define support tabs having support apertures permitting its support by a support rod. For support of the flexible container without the protective enclosure, the flexible bag may define an upper support tab having an aperture receiving a support arm. In such case the grommeted tail of the bag may have its structural integrity weakened by placing a grommet through the hole provided in the end of the bag, especially when larger capacity bags are employed. By having an injection molded extension on each half of the end of the outer package and those extensions having grommets placed in holes in the extensions, the entire protective enclosure including the FEP container and its materials may be suspended from a supporting rod, thus preventing external and internal forces from causing the bag to rupture.
Another feature afforded by the protective enclosure is to provide for easy storage of the unit on laboratory shelf space. The flat surfaces allow the user to stack the containers one on top of the other to take up a minimal amount of available shelf space, which, in most laboratories, is at a premium.
Another object of the outer package is to provide for color coding the package to identify the solvents or liquids contained therein. By providing the protective dispensing tube sleeve extended from the expanded polyurethane protective enclosure in various colors relating to the contents, it is easier for the user to identify the material contained in the package.
Another feature of the outer protective enclosure package is to provide injection molded grooves n the outer surface of the expanded polyurethane material to allow the use of strapping materials to secure the two halves of the outer package in assembly. By use of strapping materials, enough force may be exerted on the outer surface to force the enclosure halves tightly together to provide proper support to the FEP bag and its contents.
Another feature of the outer package is to allow for identification of the materials which were previously contained in an amply flexible container, so that the flexible container may be refilled with the same material. Since FEP material does have a certain limited permeability, to reuse the flexible container one must identify the material previously packaged in the container. By identifying the material previously contained, there is a possibility of refilling the bag with the same solvent thereby preventing any cross-contamination that might otherwise occur.
Another feature provided by the outer package is visual identification of the integrity of the package. Should there by any punctures, tears or holes in the outer package, there is a possibility or probability that the inner FEP container is also ruined, thus eliminating the possibility of reuse.